Ann Oncol. 2015 Jun 30. pii: mdv283. [Epub ahead of print]

Planning and Reporting of Quality of Life Outcomes in Cancer Trials.

Schandelmaier S1, Conen K2, von Elm E3, You JJ4, Blümle A5, Tomonaga Y6, Amstutz A7, Briel M8, Kasenda B9; DISCO study group.

Collaborators (40)

Author information

• 1Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Switzerland Academy of Swiss Insurance Medicine, University Hospital Basel, Basel, Switzerland.
• 2Department of Oncology, University Hospital of Basel, Switzerland.
• 3Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.
• 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
• 5German Cochrane Centre, Medical Center - University of Freiburg, Freiburg, Germany.
• 6Epidemiology, Biostatistics and Prevention Institute. University of Zurich, Zurich, Switzerland.
• 7Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Switzerland.
• 8Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Switzerland Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Clinical Research, University of Basel, Switzerland.
• 9Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Switzerland Academy of Swiss Insurance Medicine, University Hospital Basel, Basel, Switzerland Department of Medical Oncology, Royal Marsden Hospital, London, United Kingdom.

Abstract

BACKGROUND:

Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported.

DESIGN:

Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys.

RESULTS:

Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (vs. non-industry), sample size, and multi centre (vs. single centre) status but possibly with trial discontinuation.

CONCLUSIONS:

About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any quality of life data in associated publications. Highly relevant information for decision-making is often unavailable to patients, oncologists, and health-policy makers.